Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Phase 4

Active, not recruiting

• Conditions: Smoking Cessation
• Interventions: Drug: Nicotine Lozenge; Drug: Nicotine Replacement Therapy (NRT); Behavioral: Motivational Interviewing (MI); Behavioral: Message Framing; Other: saliva sample

• Registration Number: NCT03315910
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-10
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 807

Inclusion Criteria

Site Eligibility (as per SC self-report)

& Must be designated as an American College of Radiology (ACR) designated lung cancer screening site

• Reports at least one year of lung cancer screening experience
• Reports conducting at least 20 new initial screenings per month Site Coordinator (SC) Eligibility (as per SC self-report)
• Employed as a full-time Site Coordinator at participating lung cancer screening site Patient Eligibility (as per self-report)
• Between the ages of 50-80 years old
• Seeking baseline or annual follow-up LDCT lung cancer screening
• Have at least a 20 pack-year history of smoking
• Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days.
• Must be reachable by telephone
• Must be English or Spanish speaking due to the study materials being available in only these languages and limited available resources for translation.

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Exclusion Criteria

Patient (as per self-report)

• NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina).
• Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
NRT Lozenge (Yes vs. No)	Nicotine Lozenge	Participants will receive will receive 6 packs of NRT 2mg lozenge and written instructions to use the lozenge PRN to help manage acute nicotine withdrawal. Participants will be instructed to use the NRT lozenges no more than every 1-2 hours as needed. Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion \& Fulfillment.
Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)	Nicotine Replacement Therapy (NRT)	Participants will receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day and written instructions to use the patch daily starting on date they mutually agreed upon with their site coordinator. Participants who smoke fewer than 10 cigarettes per day will receive 4-weeks of the 14mg patch (2 boxes), and 2-weeks of the 7mg patch (1 box). Those who smoke 10 or more cigarettes per day will receive 4-weeks of the 21mg patch (2 boxes) and 2-weeks of the 14mg patch (1 box). Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion \& Fulfillment.
Motivational Interviewing( MI) (Yes vs. No)	saliva sample	Participants will receive two motivational informed cessation sessions; the first delivered face to faceor via telephone by the SC during the patient's initial lung cancer screening visit or during the shared decision making discussion or within about 1 week following their screening visit, and the second session delivered by telephone by the SC approximately 4 to 8 weeks after the first MI session.
Motivational Interviewing( MI) (Yes vs. No)	Motivational Interviewing (MI)	Participants will receive two motivational informed cessation sessions; the first delivered face to faceor via telephone by the SC during the patient's initial lung cancer screening visit or during the shared decision making discussion or within about 1 week following their screening visit, and the second session delivered by telephone by the SC approximately 4 to 8 weeks after the first MI session.
Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)	saliva sample	Participants will receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day and written instructions to use the patch daily starting on date they mutually agreed upon with their site coordinator. Participants who smoke fewer than 10 cigarettes per day will receive 4-weeks of the 14mg patch (2 boxes), and 2-weeks of the 7mg patch (1 box). Those who smoke 10 or more cigarettes per day will receive 4-weeks of the 21mg patch (2 boxes) and 2-weeks of the 14mg patch (1 box). Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion \& Fulfillment.
NRT Lozenge (Yes vs. No)	saliva sample	Participants will receive will receive 6 packs of NRT 2mg lozenge and written instructions to use the lozenge PRN to help manage acute nicotine withdrawal. Participants will be instructed to use the NRT lozenges no more than every 1-2 hours as needed. Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion \& Fulfillment.
Message Framing (Gain vs. Loss)	Message Framing	Overall, a robust body of health communication literature demonstrates that gain-framed messages may be more effective than loss-framed or non-framed (neutral) messages for encouraging smoking cessation. In other words, quitting messages that promote smoking cessation are more persuasive if they emphasize the benefits of quitting (gain-framed) rather than the risks (loss-framed) of persistent smoking (25, 26). Included with the written communication of their LDCT-LCS results, participants will receive a printed individualized quitting message that emphasizes either the benefits of quitting (gain-framed) or the risks of continuing to smoke (loss-framed).
Message Framing (Gain vs. Loss)	saliva sample	Overall, a robust body of health communication literature demonstrates that gain-framed messages may be more effective than loss-framed or non-framed (neutral) messages for encouraging smoking cessation. In other words, quitting messages that promote smoking cessation are more persuasive if they emphasize the benefits of quitting (gain-framed) rather than the risks (loss-framed) of persistent smoking (25, 26). Included with the written communication of their LDCT-LCS results, participants will receive a printed individualized quitting message that emphasizes either the benefits of quitting (gain-framed) or the risks of continuing to smoke (loss-framed).

Primary Outcome Measures

Name	Time	Method
number of patients who are tobacco abstinence	6 months following study enrollment	biochemical verification of smoking abstinence will be conducted Consistent with Intent to Treat, unless self reported smoking abstinence is biochemically verified, (\<3 ng/ml for mailed salivary cotinine assay) for participants who fail to return the saliva sample, the cessation outcome will be considered non-abstinent.

Trial Locations

Locations (18)

University of Southern California; 🇺🇸 Los Angeles, California, United States

WellStar Health System; 🇺🇸 LaGrange, Georgia, United States

Maine Medical Center Cancer Institute; 🇺🇸 Scarborough, Maine, United States

Munson Healthcare; 🇺🇸 Traverse City, Michigan, United States

Montefiore Medical Center (Data Collection Only); 🇺🇸 Bronx, New York, United States

NYU Winthrop Hospital; 🇺🇸 Mineola, New York, United States

Legacy Health; 🇺🇸 Portland, Oregon, United States

Carolinas Healthcare System Blue Ridge; 🇺🇸 Morganton, North Carolina, United States

John Muir Health; 🇺🇸 Walnut Creek, California, United States

MercyOne Des Moines Medical Center (Data Collection Only); 🇺🇸 Des Moines, Iowa, United States

Riverside Healthcare; 🇺🇸 Kankakee, Illinois, United States

St. Mary Medical Center, Community Healthcare System; 🇺🇸 Crown Point, Indiana, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Weill Cornell Medical Center; 🇺🇸 New York, New York, United States

Fairfield Medical Center; 🇺🇸 Lancaster, Ohio, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Henry Ford Hospital (Data collection only); 🇺🇸 Detroit, Michigan, United States